Marketing authorisations granted in July 2017
PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status
PL 34328/0015 03/07/2017 PANMEDICA ERTAPENEM 1G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ERTAPENEM SODIUM 1046.000 GRAMMES POM
PL 46091/0001 03/07/2017 INOPHARM LIMITED SEYLACINE 5 MG FILM COATED TABLET SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM
PL 46091/0002 03/07/2017 INOPHARM LIMITED SEYLACINE 10 MG FILM COATED TABLET SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM
PL 25258/0210 04/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED EMTRICITABINE/TENOFOVIR DISOPROXIL GLENMARK 200 MG/245 MG FILM-COATED TABLETS EMTRICITABINE 200 MILLIGRAMMES POM
PL 25258/0210 04/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED EMTRICITABINE/TENOFOVIR DISOPROXIL GLENMARK 200 MG/245 MG FILM-COATED TABLETS TENOFOVIR DISOPROXIL PHOSPHATE 291 MILLIGRAMMES POM
PL 00289/2099 05/07/2017 TEVA UK LIMITED BIMATOPROST/TIMOLOL TEVA 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.3 MILLIGRAMMES PER MILLILITRE POM
PL 00289/2099 05/07/2017 TEVA UK LIMITED BIMATOPROST/TIMOLOL TEVA 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES POM
PL 04416/1478 05/07/2017 SANDOZ LIMITED BIMATOPROST/TIMOLOL 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.30 MILLIGRAMMES PER MILLILITRE POM
PL 04416/1478 05/07/2017 SANDOZ LIMITED BIMATOPROST/TIMOLOL 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES PER MILLILITRE POM
PL 04569/1686 05/07/2017 GENERICS (UK) LIMITED BIMATOPROST/TIMOLOL MYLAN 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.3 MILLIGRAMMES PER MILLILITRE POM
PL 04569/1686 05/07/2017 GENERICS (UK) LIMITED BIMATOPROST/TIMOLOL MYLAN 0.3 MG/ML + 5 MG/ML EYE DROPS, SOLUTION TIMOLOL MALEATE 6.8 MILLIGRAMMES PER MILLILITRE POM
PL 44305/0008 06/07/2017 KOANAA HEALTHCARE LIMITED IRINOTECAN HYDROCHLORIDE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40.00 MILLIGRAMMES POM
PL 04569/1684 07/07/2017 GENERICS (UK) LIMITED BIMATOPROST MYLAN 0.1 MG/ML EYE DROPS, SOLUTION BIMATOPROST 0.10 MILLIGRAMMES PER MILLILITRE POM
PL 16239/0044 07/07/2017 MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S A ILAXTEN 10MG ORODISPERSIBLE TABLETS BILASTINE 10 MILLIGRAMMES POM
PL 16239/0045 07/07/2017 MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S A ILAXTEN 2.5MG/ML ORAL SOLUTION BILASTINE 2.5 MILLIGRAMMES PER MILLILITRE POM
PL 21880/0167 07/07/2017 MEDREICH PLC TRAMADOL HYDROCHLORIDE 50 MG CAPSULES TRAMADOL HYDROCHLORIDE 50 MILLIGRAMMES POM
PL 25298/0047 07/07/2017 BROWN & BURK UK LIMITED SOLIFENACIN 5 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM
PL 25298/0048 07/07/2017 BROWN & BURK UK LIMITED SOLIFENACIN 10 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM
PL 44041/0037 07/07/2017 NOUMED LIFE SCIENCES LIMITED TRAMADOL HYDROCHLORIDE 50 MG CAPSULES TRAMADOL HYDROCHLORIDE 50 MILLIGRAMMES POM
PL 00010/0663 10/07/2017 BAYER PLC NASONEX ALLERGY DEFENCE 0.05% NASAL SPRAY MOMETASONE FUROATE MONOHYDRATE 0.5 MILLIGRAMMES PER GRAM P
PL 17907/0614 10/07/2017 BRISTOL LABORATORIES LIMITED IVABRADINE 5 MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 5.39 MILLIGRAMMES POM
PL 17907/0615 10/07/2017 BRISTOL LABORATORIES LIMITED IVABRADINE 7.5 MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 8.085 MILLIGRAMMES POM
PL 41947/0030 10/07/2017 ELC GROUP SRO DEXAMETHASONE 3.3 MG/ML, SOLUTION FOR INJECTION DEXAMETHASONE SODIUM PHOSPHATE 4.37 MILLIGRAMMES PER MILLILITRE POM
PL 46091/0003 10/07/2017 INOPHARM LIMITED GIRAXINE 5 MG FILM-COATED TABLET SOLIFENACIN SUCCINATE 5 MILLIGRAMMES POM
PL 46091/0004 10/07/2017 INOPHARM LIMITED GIRAXINE 10 MG FILM-COATED TABLET SOLIFENACIN SUCCINATE 10 MILLIGRAMMES POM
PL 00063/0740 11/07/2017 RECKITT BENCKISER HEALTHCARE (UK) LIMITED SCHOLLMED ONCE WEEKLY FUNGAL NAIL TREATMENT 5%W/V MEDICATED NAIL LACQUER AMOROLFINE HYDROCHLORIDE 55.74 MILLIGRAMMES PER MILLILITRE P
PL 00289/2104 11/07/2017 TEVA UK LIMITED BORTEZOMIB TEVA 2.5 MG POWDER FOR SOLUTION FOR INJECTION BORTEZOMIB 2.5 MILLIGRAMMES POM
PL 14048/0255 11/07/2017 SYNTHON BV ANAGRELIDE 0.5 MG HARD CAPSULES ANAGRELIDE HYDROCHLORIDE MONOHYDRATE 0.61 MILLIGRAMMES POM
PL 25258/0226 11/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED LECOMIG 600 MG FILM-COATED TABLETS GABAPENTIN 600.00 MILLIGRAMMES POM
PL 25258/0227 11/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED LECOMIG 800 MG FILM-COATED TABLETS GABAPENTIN 800.00 MILLIGRAMMES POM
PL 35507/0183 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 10 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 10.400 MILLIGRAMMES POM
* POM = Prescription only medicine 1 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017
PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status
PL 35507/0184 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 20 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 20.800 MILLIGRAMMES POM
PL 35507/0185 12/07/2017 LUPIN (EUROPE) LIMITED ROSUVASTATIN 40 MG FILM-COATED TABLETS ROSUVASTATIN CALCIUM 41.600 MILLIGRAMMES POM
PL 43801/0043 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 250 MG FILM-COATED TABLETS LEVETIRACETAM 250 MILLIGRAMMES POM
PL 43801/0044 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 500 MG FILM-COATED TABLETS LEVETIRACETAM 500 MILLIGRAMMES POM
PL 43801/0045 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 750 MG FILM-COATED TABLETS LEVETIRACETAM 750 MILLIGRAMMES POM
PL 43801/0046 12/07/2017 SCIECURE PHARMA LIMITED LEVETIRACETAM SCIECURE 1000 MG FILM-COATED TABLETS LEVETIRACETAM 1000 MILLIGRAMMES POM
PL 20416/0343 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 8MG/12.5MG TABLETS CANDESARTAN CILEXETIL 8.00 MILLIGRAMMES POM
PL 20416/0343 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 8MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.50 MILLIGRAMMES POM
PL 20416/0344 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 16MG/12.5MG TABLETS CANDESARTAN CILEXETIL 16.00 MILLIGRAMMES POM
PL 20416/0344 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 16MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM
PL 20416/0345 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/12.5MG TABLETS CANDESARTAN CILEXETIL 32.00 MILLIGRAMMES POM
PL 20416/0345 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/12.5MG TABLETS HYDROCHLOROTHIAZIDE 12.50 MILLIGRAMMES POM
PL 20416/0346 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/25MG TABLETS CANDESARTAN CILEXETIL 32.00 MILLIGRAMMES POM
PL 20416/0346 14/07/2017 CRESCENT PHARMA LIMITED CANDESARTAN AND HYDROCHLOROTHIAZIDE 32MG/25MG TABLETS HYDROCHLOROTHIAZIDE 25.00 MILLIGRAMMES POM
PL 35533/0095 14/07/2017 ASPIRE PHARMA LIMITED MEBEVERINE 200MG MODIFIED RELEASE CAPSULES MEBEVERINE HYDROCHLORIDE 200.00 MILLIGRAMMES POM
PL 08553/0594 17/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED NEVIRAPINE DR. REDDY'S 400 MG PROLONGED-RELEASE TABLETS NEVIRAPINE ANHYDROUS 400 MILLIGRAMMES POM
PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION MACROGOL 3350 6562.50 MILLIGRAMMES POM
PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION POTASSIUM CHLORIDE 23.300 MILLIGRAMMES POM
PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION SODIUM CHLORIDE 175.350 MILLIGRAMMES POM
PL 28176/0183 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 6.86G PAEDIATRIC POWDER FOR ORAL SOLUTION SODIUM HYDROGEN CARBONATE 89.250 MILLIGRAMMES POM
PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION MACROGOL 3350 13125.00 MILLIGRAMMES POM
PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION POTASSIUM CHLORIDE 46.600 MILLIGRAMMES POM
PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION SODIUM CHLORIDE 350.700 MILLIGRAMMES POM
PL 28176/0184 17/07/2017 STRIDES ARCOLAB INTERNATIONAL LIMITED COMPOUND MACROGOL 13.72G POWDER FOR ORAL SOLUTION SODIUM HYDROGEN CARBONATE 178.500 MILLIGRAMMES POM
PL 30322/0021 17/07/2017 ALISSA HEALTHCARE RESEARCH LIMITED VITAMIN D3 800 IU CAPSULES, SOFT COLECALCIFEROL 0.0220 MILLIGRAMMES POM
PL 32854/0038 18/07/2017 GALENICUM HEALTH SL TIGECYCLINE 50 MG POWDER FOR SOLUTION FOR INFUSION TIGECYCLINE 50 MILLIGRAMMES PER 5 MILLILITRESPOM
PL 08553/0600 19/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED FEBUXOSTAT DR. REDDY'S 80 MG FILM-COATED TABLETS FEBUXOSTAT HEMIHYDRATE 82.28 MILLIGRAMMES POM
PL 08553/0601 19/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED FEBUXOSTAT DR. REDDY'S 120 MG FILM-COATED TABLETS FEBUXOSTAT HEMIHYDRATE 123.42 MILLIGRAMMES POM
PL 20075/0488 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 10.34 MILLIGRAMMES POM
PL 20075/0489 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 20.68 MILLIGRAMMES POM
PL 20075/0490 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 40 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 41.36 MILLIGRAMMES POM
* POM = Prescription only medicine 2 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017
PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status
PL 20075/0491 19/07/2017 ACCORD HEALTHCARE LIMITED ATORVASTATIN 80 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 82.72 MILLIGRAMMES POM
PL 20117/0265 19/07/2017 MORNINGSIDE HEALTHCARE LIMITED ACITRETIN 10 MG CAPSULES ACITRETIN 10.00 MILLIGRAMMES POM
PL 20117/0266 19/07/2017 MORNINGSIDE HEALTHCARE LIMITED ACITRETIN 25 MG CAPSULES ACITRETIN 25.00 MILLIGRAMMES POM
PL 40170/0012 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 10.34 MILLIGRAMMES POM
PL 40170/0013 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 20.68 MILLIGRAMMES POM
PL 40170/0014 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 30 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 31.02 MILLIGRAMMES POM
PL 40170/0015 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 40 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 41.36 MILLIGRAMMES POM
PL 40170/0016 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 60 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 62.04 MILLIGRAMMES POM
PL 40170/0017 19/07/2017 DSM SINOCHEM PHARMACEUTICALS NETHERLANDS BV ATORVASTATIN 80 MG FILM-COATED TABLETS ATORVASTATIN CALCIUM TRIHYDRATE 82.72 MILLIGRAMMES POM
PL 10592/0303 20/07/2017 SMITHKLINE BEECHAM LIMITED AUGMENTIN 400/57 POWDER FOR ORAL SUSPENSION AMOXICILLIN TRIHYDRATE 459.17 MILLIGRAMMES PER 5 MILLILITRESPOM
PL 10592/0303 20/07/2017 SMITHKLINE BEECHAM LIMITED AUGMENTIN 400/57 POWDER FOR ORAL SUSPENSION POTASSIUM CLAVULANATE 67.90 MILLIGRAMMES PER 5 MILLILITRESPOM
PL 16363/0504 20/07/2017 MILPHARM LIMITED PARACETAMOL 500 MG TABLETS PARACETAMOL 500.00 MILLIGRAMMES P
PL 16363/0505 20/07/2017 MILPHARM LIMITED PARACETAMOL 500MG TABLETS PARACETAMOL 500.00 MILLIGRAMMES POM
PL 16363/0517 20/07/2017 MILPHARM LIMITED PARACETAMOL 500 MG TABLETS PARACETAMOL 500.000 MILLIGRAMMES GSL
PL 27827/0038 20/07/2017 GALEN LIMITED NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS NEFOPAM HYDROCHLORIDE 30.00 MILLIGRAMMES POM
PL 36390/0218 21/07/2017 CIPLA (EU) LIMITED TADALAFIL 2.5 MG FILM-COATED TABLETS TADALAFIL 2.5 MILLIGRAMMES POM
PL 36390/0219 21/07/2017 CIPLA (EU) LIMITED TADALAFIL 5 MG FILM-COATED TABLETS TADALAFIL 5 MILLIGRAMMES POM
PL 36390/0220 21/07/2017 CIPLA (EU) LIMITED TADALAFIL 10 MG FILM-COATED TABLETS TADALAFIL 10 MILLIGRAMMES POM
PL 36390/0221 21/07/2017 CIPLA (EU) LIMITED TADALAFIL 20 MG FILM-COATED TABLETS TADALAFIL 20 MILLIGRAMMES POM
PL 36390/0222 21/07/2017 CIPLA (EU) LIMITED TADALAFIL 20 MG FILM-COATED TABLETS TADALAFIL 20 MILLIGRAMMES POM
PL 44124/0008 21/07/2017 PANPHARMA HEPARIN SODIUM 5 000 I.U./ML, SOLUTION FOR INJECTION HEPARIN SODIUM 5000 INTERNATIONAL UNITS PER ML POM
PL 05889/0001 24/07/2017 MEDICHEM SA DAPTOMYCIN 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION DAPTOMYCIN 350.00 MILLIGRAMMES POM
PL 05889/0002 24/07/2017 MEDICHEM SA DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION DAPTOMYCIN 500.00 MILLIGRAMMES POM
PL 21880/0006 24/07/2017 MEDREICH PLC IVABRADINE 5MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 5.39 MILLIGRAMMES POM
PL 21880/0205 24/07/2017 MEDREICH PLC IVABRADINE 7.5MG FILM-COATED TABLETS IVABRADINE HYDROCHLORIDE 8.085 MILLIGRAMMES POM
PL 28395/0111 24/07/2017 PHARMADREAMS LIMITED CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED 500.00 MILLIGRAMMES POM
PL 28395/0112 24/07/2017 PHARMADREAMS LIMITED CEFTAZIDIME 1.0 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED 1.00 GRAMMES POM
PL 28395/0113 24/07/2017 PHARMADREAMS LIMITED CEFTAZIDIME 2.0 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED 2.00 GRAMMES POM
PL 08553/0583 25/07/2017 DR REDDY'S LABORATORIES (UK) LIMITED FULVESTRANT DR. REDDY'S 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE FULVESTRANT 250.000 MILLIGRAMMES POM
PL 17780/0812 25/07/2017 WINTHROP PHARMACEUTICALS UK LIMITED BORTEZOMIB ZENTIVA 3.5 MG POWDER FOR SOLUTION FOR INJECTION BORTEZOMIB 3.5 MILLIGRAMMES POM
PL 20075/0487 25/07/2017 ACCORD HEALTHCARE LIMITED PHENYTOIN ACCORD 50 MG/ML SOLUTION FOR INJECTION/INFUSION PHENYTOIN SODIUM 50 MILLIGRAMMES POM
* POM = Prescription only medicine 3 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017
PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status
PL 33155/0070 25/07/2017 RIVOPHARM (UK) LIMITED FEBUXOSTAT 80MG FILM-COATED TABLETS FEBUXOSTAT 80 MILLIGRAMMES POM
PL 33155/0071 25/07/2017 RIVOPHARM (UK) LIMITED FEBUXOSTAT 120 MG FILM-COATED TABLETS FEBUXOSTAT 120.00 MILLIGRAMMES POM
PL 36722/0060 25/07/2017 SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED SIMVASTATIN 10MG TABLETS SIMVASTATIN 10.000 MILLIGRAMMES POM
PL 36722/0061 25/07/2017 SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED SIMVASTATIN 20MG TABLET SIMVASTATIN 20.000 MILLIGRAMMES POM
PL 36722/0062 25/07/2017 SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED SIMVASTATIN 40MG TABLETS SIMVASTATIN 40.00 MILLIGRAMMES POM
PL 43808/0010 25/07/2017 ENDO VENTURES LIMITED FLUOXETINE 10 MG FILM-COATED TABLETS FLUOXETINE HYDROCHLORIDE 11.178 MILLIGRAMMES POM
PL 46302/0055 25/07/2017 MYLAN PRODUCTS LIMITED INFLUVAC SUB-UNIT TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) 15.000 MICROGRAMMES POM
PL 46302/0055 25/07/2017 MYLAN PRODUCTS LIMITED INFLUVAC SUB-UNIT TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A) 15.000 MICROGRAMMES POM
PL 46302/0055 25/07/2017 MYLAN PRODUCTS LIMITED INFLUVAC SUB-UNIT TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE B/BRISBANE/60/2008 15.000 MICROGRAMMES POM
PL 46302/0055 25/07/2017 MYLAN PRODUCTS LIMITED INFLUVAC SUB-UNIT TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B) 15.000 MICROGRAMMES POM
PL 46302/0056 25/07/2017 MYLAN PRODUCTS LIMITED INFLUENZA VACCINE TETRA MYL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN (A/CALIFORNIA/7/2009, X-181) 15.000 MICROGRAMMES POM
PL 46302/0056 25/07/2017 MYLAN PRODUCTS LIMITED INFLUENZA VACCINE TETRA MYL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE A/TEXAS/50/2012 (H3N2)-LIKE STRAIN (A/TEXAS/50/2012, X-223A) 15.000 MICROGRAMMES POM
PL 46302/0056 25/07/2017 MYLAN PRODUCTS LIMITED INFLUENZA VACCINE TETRA MYL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE B/BRISBANE/60/2008 15.000 MICROGRAMMES POM
PL 46302/0056 25/07/2017 MYLAN PRODUCTS LIMITED INFLUENZA VACCINE TETRA MYL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE B/MASSACHUSETTS/2/2012-LIKE STRAIN (B/MASSACHUSETTS/2/2012, BX-51B) 15.000 MICROGRAMMES POM
PL 08215/0104 26/07/2017 KENT PHARMACEUTICALS LIMITED ENTECAVIR KENT 0.5 MG FILM-COATED TABLET ENTECAVIR MONOHYDRATE 0.53 MILLIGRAMMES POM
PL 08215/0105 26/07/2017 KENT PHARMACEUTICALS LIMITED ENTECAVIR KENT 1 MG FILM-COATED TABLET ENTECAVIR MONOHYDRATE 1.06 MILLIGRAMMES POM
PL 24065/0004 26/07/2017 LABORATORIOS AZEVEDOS INDUSTRIA FARMACEUTICA SA ACICLOVIR 250 MG, POWDER FOR SOLUTION FOR INFUSION ACICLOVIR SODIUM 274.402 MILLIGRAMMES POM
PL 36722/0098 26/07/2017 SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED ATENOLOL 50MG TABLETS ATENOLOL 50 MILLIGRAMMES POM
PL 36722/0099 26/07/2017 SPECIAL CONCEPT DEVELOPMENT (UK) LIMITED ATENOLOL 100MG TABLETS ATENOLOL 100 MILLIGRAMMES POM
PL 42357/0225 26/07/2017 AMNEAL PHARMA EUROPE LIMITED TENOFOVIR DISOPROXIL 245 MG FILM-COATED TABLETS TENOFOVIR DISOPROXIL PHOSPHATE 291 MILLIGRAMMES POM
PL 42357/0227 26/07/2017 AMNEAL PHARMA EUROPE LIMITED DRELBISTA 245 MG FILM-COATED TABLETS TENOFOVIR DISOPROXIL FUMARATE 300 MILLIGRAMMES POM
PL 43801/0031 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 80/12.5MG FILM COATED TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM
PL 43801/0031 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 80/12.5MG FILM COATED TABLETS VALSARTAN 80 MILLIGRAMMES POM
PL 43801/0032 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 160/12.5MG FILM COATED TABLETS HYDROCHLOROTHIAZIDE 12.5 MILLIGRAMMES POM
PL 43801/0032 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 160/12.5MG FILM COATED TABLETS VALSARTAN 160 MILLIGRAMMES POM
PL 43801/0033 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 160/25MG FILM COATED TABLETS HYDROCHLOROTHIAZIDE 25 MILLIGRAMMES POM
PL 43801/0033 26/07/2017 SCIECURE PHARMA LIMITED VALSARTAN HYDROCHLOROTHIAZIDE 160/25MG FILM COATED TABLETS VALSARTAN 160 MILLIGRAMMES POM
PL 17277/0367 27/07/2017 PHARMATHEN SA ENTECAVIR 0.5 MG FILM-COATED TABLETS ENTECAVIR MONOHYDRATE 0.53 MILLIGRAMMES POM
PL 17277/0368 27/07/2017 PHARMATHEN SA ENTECAVIR 1 MG FILM-COATED TABLETS ENTECAVIR MONOHYDRATE 1.06 MILLIGRAMMES POM
PL 20416/0390 27/07/2017 CRESCENT PHARMA LIMITED RISEDRONATE SODIUM 5 MG FILM-COATED TABLETS RISEDRONATE SODIUM HEMIPENTAHYDRATE 5.74 MILLIGRAMMES POM
PL 20416/0391 27/07/2017 CRESCENT PHARMA LIMITED RISEDRONATE SODIUM 30 MG FILM-COATED TABLETS RISEDRONATE SODIUM HEMIPENTAHYDRATE 34.43 MILLIGRAMMES POM
* POM = Prescription only medicine 4 P = Pharmacy only medicine GSL = General Sale List Marketing authorisations granted in July 2017
PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status
PL 20416/0392 27/07/2017 CRESCENT PHARMA LIMITED RISEDRONATE SODIUM 35 MG FILM-COATED TABLETS RISEDRONATE SODIUM HEMIPENTAHYDRATE 40.17 MILLIGRAMMES POM
PL 00289/2063 28/07/2017 TEVA UK LIMITED TOVEDESO 3.5MG PROLONGED-RELEASE TABLETS DESFESOTERODINE SUCCINATE 3.50 MILLIGRAMMES POM
PL 00289/2064 28/07/2017 TEVA UK LIMITED TOVEDESO 7MG PROLONGED-RELEASE TABLETS DESFESOTERODINE SUCCINATE 7.00 MILLIGRAMMES POM
PL 20075/0515 28/07/2017 ACCORD HEALTHCARE LIMITED MITOMYCIN 40 MG, POWDER FOR SOLUTION FOR INJECTION/INFUSION MITOMYCIN 40 MILLIGRAMMES POM
PL 25258/0211 28/07/2017 GLENMARK PHARMACEUTICALS EUROPE LIMITED TENOFOVIR DISOPROXIL 245 MG FILM-COATED TABLETS TENOFOVIR DISOPROXIL PHOSPHATE 291.0 MILLIGRAMMES POM
PL 36687/0205 31/07/2017 TORRENT PHARMA (UK) LIMITED PIOGLITAZONE/METFORMIN 15 MG/850 MG FILM-COATED TABLETS METFORMIN HYDROCHLORIDE 850.000 MILLIGRAMMES POM
PL 36687/0205 31/07/2017 TORRENT PHARMA (UK) LIMITED PIOGLITAZONE/METFORMIN 15 MG/850 MG FILM-COATED TABLETS PIOGLITAZONE HYDROCHLORIDE 16.536 MILLIGRAMMES POM
* POM = Prescription only medicine 5 P = Pharmacy only medicine GSL = General Sale List